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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Goruntla 2019.

Study characteristics
Methods Impact of pharmacist‐directed counseling and message reminder services on medication adherence and clinical outcomes in type 2 diabetes mellitus
RCT (NA clusters and NA providers), conducted in 1) The trial was carried out in outpatient medical department of a secondary care referral hospital, which was located in resource limited settings in Anantapuramu District, Andhra Pradesh, India. 2) Patients received pharmacist counselling and mobile phone daily messages about medication intake in India
2 arms: 1. Control (usual care by physician) (control arm) and 2. Intervention (pharmacist counselling and daily messages) (intervention arm)
Participants Control arm N: 165
Intervention arm N: 165, NA, NA
Diabetes type: 2
Mean age: 58.8 ± 10.7
% Male: 51.8
Longest follow‐up: 6 months
Interventions Control arm: (usual care by physician)
Intervention arm: (pharmacist counselling and daily messages)
1) Case management
2) Team change
3) Patient education
4) Patient reminders
Outcomes Glycated haemoglobin
Systolic blood pressure
Low‐density lipoprotein
Funding source Financial support and sponsorship: nil
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not reported. 330 patients who met study criteria were enrolled and randomised into intervention (n = 165) and control (n = 165) group by simple randomisation technique.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values above 0.05. Quote: "Sociodemographic characteristics, such as gender, marital status, education, occupation, comorbidities, and duration of diabetes, were closely matched in intervention and control groups as depicted in Table 1."
Patient's baseline outcomes (selection bias) Low risk Table 1: P value above 0.05 for BMI at baseline. Table 5: P values above 0.05 for HbA1c, SBP, LDL, TG and BMI at baseline.
Incomplete outcome data (attrition bias) Low risk In intervention group, 14 and in control group, 10 participants failed to show up for follow‐up visits. A total of 151/165 (8.5% lost) in intervention and 155/165 (6.1%) in the control group were subjected to data analysis. The flowchart of participants is shown in Figure 1. Low and balanced numbers of lost.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk All of our outcomes of interest were objectively assessed (HbA1c, SBP and LDL).
Selective reporting (reporting bias) Unclear risk No published or registered protocol. They reported data on SBP but not on DBP, and they do not explain why.
Risk of contamination (other bias) Low risk Patient RCT, but it is unlikely that control patients received pharmacist directed counselling or text messages.
Other bias Low risk No evidence of other risk of bias